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Proportion of patients achieving an objective response that lasts at least 4 months [ Time Frame: Until disease progression, death or study closure (up to 3 years after the enrollment of the last patient) ]

To determine ORR, lasting at least 4 months, with brentuximab vedotin in patients with CD30+ MF or pcALCL compared to that achieved with therapy in the control arm

Original Primary Outcome Measures ICMJE (submitted: April 13, 2012)

Proportion of patients achieving an objective response that lasts at least 4 months [ Time Frame: Change in response at the end of 21 day cycles: 3,6,9,12, and 15; at EOT; then every 12 weeks for a minimum of 24 months, and thereafter every 6 months until disease progression or study closure for up to 3 years post treatment ]

To determine ORR, lasting at least 4 months, with brentuximab vedotin in patients with CD30+ MF or pcALCL compared to that achieved with therapy in the control arm

Proportion of patients achieving complete response (CR) [ Time Frame: Until disease progression, death or study closure (up to 3 years after the enrollment of the last patient) ]

To determine CR rate with brentuximab vedotin compared to that achieved with therapy in the control arm

Progression-free survival (PFS) [ Time Frame: Until disease progression, death or study closure (up to 3 years after the enrollment of the last patient) ]

To determine PFS with brentuximab vedotin compared to that achieved with therapy in the control arm

Changes in symptom domain per Skindex-29 questionnaire [ Time Frame: Until disease progression, death or study closure (up to 3 years after the enrollment of the last patient) ]

To determine burden of symptoms during treatment with brentuximab vedotin compared to that achieved with therapy in the control arm

Original Secondary Outcome Measures ICMJE (submitted: April 13, 2012)

Proportion of patients achieving complete response (CR) [ Time Frame: At the end of 21 day cycles: 3,6,9,12, and 15; at EOT; then every 12 weeks for a minimum of 24 months, and thereafter every 6 months until disease progression or study closure for up to 3 years post treatment ]

To determine CR rate with brentuximab vedotin compared to that achieved with therapy in the control arm

Progression-free survival (PFS) [ Time Frame: At the end of 21 day cycles: 3,6,9,12, and 15; at EOT; then every 12 weeks for a minimum of 24 months, and thereafter every 6 months until disease progression or study closure for up to 3 years post treatment ]

To determine PFS with brentuximab vedotin compared to that achieved with therapy in the control arm

Changes in symptom domain per Skindex-29 questionnaire [ Time Frame: Day 1 of 21 day cycles: 1,2,4,6,8,10,12,14, and 16; At EOT 30 days after the last dose, and during post treatment follow-up (for up to 3 years post treatment) ]

To determine burden of symptoms during treatment with brentuximab vedotin compared to that achieved with therapy in the control arm

Brentuximab vedotin (1.8 mg/kg) will be administered intravenously over approximately 30 minutes once every 21 days and may continue as monotherapy for up to a total of 16 cycles (48 weeks)

Other Name: SGN-35

Drug: Methotrexate or Bexarotene

Methotrexate will be administered orally (5 to 50 mg) once weekly. Dose adjustment is guided by patient response and toxicity or Bexarotene will be administered orally (300 mg/m2) once daily with meals.

Female patients who are post menopausal, surgically sterile, or agree to practice 2 effective methods of contraception or agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the subject

Male patients who agree to practice effective barrier contraception or agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the subject

Oral retinoid therapy for any indication within 3 weeks of study entry

Corticosteroid therapy within 3 weeks or immunosuppressive chemotherapy or any antibody-directed or immunoglobulin-based immune therapy (eg, immunoglobulin replacement, other monoclonal antibody therapies) within 12 weeks of first dose of study drug

Female patients who are lactating and breastfeeding or have a positive serum pregnancy test during the screening period or a positive urine pregnancy test on Day 1 of any cycle

Previous receipt of brentuximab vedotin

Please note that there are additional inclusion and exclusion criteria. The study center will determine if you meet all of the criteria.

Site personnel will explain the trial in detail and answer any question you may have if you do qualify for the study. You can then decide whether or not you wish to participate. If you do not qualify for the trial, site personnel will explain the reasons.

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Senior)

Accepts Healthy Volunteers

No

Contacts ICMJE

Contact information is only displayed when the study is recruiting subjects